(256 days)
The Verigene CFTR and Verigene®CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices used to genotype a panel of mutations and variants in vitro transmembrance regulator (CFTA) consisted institute and variants in the cystic fibrosis transmission is see about to the of micrations and variants in the cystic fibrosis transmembrance regulator (CFFT) gene in genomic DNA isolated from human peripheral whole blood (CF7 / ) gene includes mutations and variations and variations and virus and virus and variations and variations and variations and Obstericians and Gyneologists (ACOG). The Verigene CFTA Nucleic Acid Test provides information intended to be used for carrier testing in adults of reproductive age and in confirmatory diagnostic testing of newborns and children. These tests are not indicated for use in fetal diagnostic or pre-implantation testing and not indicated for stand-alone is in retal dagnostic of pre-implantation testing and not indicated for stand-alone diagnostic purposes. The results should be used in conjunction w other available alono diagnostic purposes. The results should be used in conjunction with other available laboratory and clinical information. Both tests are intended to be u
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This document is an FDA 510(k) clearance letter for the Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Tests. It primarily focuses on the regulatory aspects and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria.
Therefore, I cannot provide the requested information based solely on the provided text. The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on information provided in the 510(k) submission itself, which would include performance data, but that data is not present in this clearance letter.
To answer your request, I would need access to the actual 510(k) premarket notification submission (document K083294) from Nanosphere, Inc., which would contain the performance study details.
However, based on the general nature of such submissions, I can infer what typical elements would be included, but I cannot provide specific data from this document.
If you can provide the 510(k) submission document (K083294), I would be able to extract the specific information you are looking for.
§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
(a)
Identification. The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.